This study is a pharmacokinetic study designed to evaluate the effect of food on the oral bioavailability and effect of diurnal variation on the pharmacokinetics of ABT-869. Triplicate ECG performed to determine the effect of ABT-869 on QT prolongation . Subjects may continue receiving linifanib after completion of the study.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Male or female and age is ≥ 18 years.

Must have a histologically or cytologically confirmed non-hematologic malignancy that is refractory to standard therapies or for which a standard effective therapy does not exist.

Has measurable or evaluable disease.

Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.

Must have adequate bone marrow, renal and hepatic function as follows:

Women of childbearing potential and men must agree to use adequate contraception (one of the following listed below) prior to study entry, for the duration of study participation and up to two months following completion of therapy. Women of childbearing potential must have a negative urine pregnancy test within 7 days prior to initiation of treatment and/or post menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.

total abstinence from sexual intercourse (minimum one complete menstrual cycle);

Is capable of understanding and complying with parameters as outlined in the protocol and able to sign the informed consent.

Must voluntarily sign and date each informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

Has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration. Has not recovered to less than or equal to Grade 1 clinically significant adverse effects/toxicities of the previous therapy. Avastin must not have been used less than 60 days prior to receiving ABT-869.

Has had major surgery within 21 days of Study Day 1.

Has untreated brain or meningeal metastases. Subjects with treated, stable, asymptomatic central nervous system lesions may be considered. Subject must have had stable disease for at least 4 weeks prior to study entry.

Has a history of/or currently exhibits clinically significant cancer related events of bleeding. The subject has a recent history of (within 4 weeks of Study Day 1) or currently exhibits other clinically significant signs of bleeding.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00733187